Kornimate/medical-research-clean huggingface dataset:
β-globin restored autologous hsc in β-thalassemia major patients

Conditions: β-thalassemia Major

Summary: this is a single center, single arm, open-label study to determine the safety and efficacy of β-globin restored autologous hematopoietic stem cells in β- thalassemia major patients with cvs-654 mutation.

β-globin restored autologous hematopoietic stem cells will be manufactured using crispr/cas9 gene editing system. subject participation for this study will be 1 year. subjects who enroll in this study will be asked to participate in a subsequent long-term follow up study that will monitor the safety and efficacy of the treatment they receive for up to 15 years post-transplant.

Eligibility criteria:
inclusion criteria: * 5-15 years old. clinically diagnosed as β-thalassemia major with ivs-654 gene mutation phenotype; * subjects or at least one legal guardian/agent understand and voluntarily sign informed consent. * subjects with no affection with ebv, hiv, cmv, tp, hav, hbv and hcv. * subjects body condition eligible for autologous stem cell transplant. exclusion criteria: - subjects acceptable for allogeneic hematopoietic stem cell transplantation and have an available fully matched related donor. active bacterial, viral, or fungal infection. treated with erythropoietin prior 3 months. immediate family member with any known hematological tumor. subjects with severe psychiatric disorders to be unable to cooperate. recently diagnosed as malaria. history of complex autoimmune disease. persistent aspartate transaminase (ast), alanine transaminase (alt), or total bilirubin value \>3 x the upper limit of normal (uln). subjects with severe heart, lung and kidney diseases. with serious iron overload. any other condition that would render the subject ineligible for hsct, as determined by the attending transplant physician or investigator. subjects who are receiving treatment from another clinical study, or have received another gene therapy. subjects or guardians had resisted the guidance of the attending doctor. subjects whom the investigators do not consider appropriate for participating in this clinical study.
effects of lifestyle-modification induced weight loss on sexual and urinary function, and quality of life in obese men

Conditions: Sexual Dysfunction; Endothelial Dysfunction; Quality of Life; Inflammation

Summary: this study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (luts), and quality of life in obese men.

this study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (luts), and quality of life in obese men.men aged 30-65 years, with body mass index (bmi) ≥ 27.5 kg/m2, will be recruited from referrals to the sports medicine centre in changi general hospital. the study will be conducted at the sports medicine centre by trained medical investigators, dieticians and sports trainers.at baseline, 12 and 24 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum c-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive endopat method, and validated questionnaires administered to assess changes in erectile function, sexual desire, luts and quality of life

Eligibility criteria:
inclusion criteria: * male, aged 30-65 years * body mass index (bmi) \>/= 27.5 kg/m2 * waist circumference (wc) \>/= 90 cm exclusion criteria: * pituitary disease or cranial radiotherapy * previous or current androgen replacement or deprivation therapy * current treatment for sexual problems or luts * glomerular filtration rate \< 60 ml/min * liver disease * alcohol intake exceeding 500 g/week in the previous 12 months * use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors

Keywords: obesity men sexual function urinary tract symptoms endothelial function inflammation quality of life
deepview snapshot portable (dv-ssp): device training study

Conditions: Burns; Wound Heal

Summary: the purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the spectral md deepview device and provide burn healing potential assessment.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent or have a legally authorized representative (lar) able to do so; * life expectancy \> 6 months; * thermal burn mechanism (flame, scald, or contact); * the study burn(s) occurred less than 72 hours prior to the time of first imaging; and * minimum burn wound size for adult or pediatric patients is 0.5% tbsa per region * for adult subjects: have 2 - 4 regions of their clinical burn(s) that meet the criteria for a study burn. * for pediatric subjects: have 1 - 4 regions of their clinical burn(s) that meet the criteria for a study burn exclusion criteria: * burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; * subject has burns involving \> 50% total body surface area (tbsa); * sepsis at the time of enrollment; * immunosuppression/radiation/chemotherapy \< 3 months prior to enrollment; * concurrent use of investigational products with a known effect on the burn sites; and/or * any condition that in the opinion of the investigator may prevent compliance with the study requirements or compromise subject safety.
elucidation of the mechanisms and effects of certain anesthetic interventions on digestive cancer patients subjected to surgery

Conditions: Colorectal Cancer

Summary: digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.


Eligibility criteria:
inclusion criteria: * 18 to 80 years old patients admitted for elective colorectal surgery exclusion criteria: * pre-existing chronic pain * chronic medication that may interfere with pain: antiepileptics, nsaids, corticosteroids * contraindications to any of the medications in the study * significant psychiatric disorders (axis i disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.) * hepatic (alt and / or ast\> 2 normal wave) or renal (serum creatinine\> 2 mg / dl) * convulsive conditions that require medication in the last 2 years * planned regional analgesia and / or anesthesia (spinal or epidural) * corticosteroid-dependent asthma * autoimmune disorders * antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine

Keywords: anesthesia propofol sevoflurane lidocaine cell culture
feasibility of a sensor-less sleep monitor (somnofy®) in diagnosis and follow-up in obstructive sleep apnea.

Conditions: Obstructive Sleep Apnea

Summary: to evaluate the feasibility of a sensor-less sleep monitor (somnofy®) in diagnosis and follow-up in obstructive sleep apnea. the study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.

a single-center prospective feasibility study. the study device is somnofy®, a sensor-less commercially available sleep monitor. the ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. the somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device nox-t3 and the osas event data from the metronics airview software from cpap. thus, it will be possible to assess if somnofy® is able to detect the events registered from the diagnostic equipment. for patients started on continous positive airway pressure (cpap) treatment, a new registration with somnofy® will be performed 12 weeks after treatment initiation. the effect of obstructive sleep apnea on patient and partner reported outcomes before and after cpap initiation will also be assessed through questionnaires and journals.

Eligibility criteria:
inclusion criteria: * referred to the pulmonology department in the participating hospital (sykehuset levanger) with suspected sleep apnea * able to sign an informed consent exclusion criteria: * pregnancy * serious disease which could affect ability to complete the study * complicated sleep disorders

Keywords: sleep monitor
efficacy and safety of valsartan/amlodipine combination in patients with severe hypertension

Conditions: Hypertension

Summary: this study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension


Eligibility criteria:
inclusion criteria: * patients with severe hypertension exclusion criteria: * history of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm * liver, kidney, or pancreas disease * insulin dependent diabetes * allergy to certain medications used to treat high blood pressure other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypertension high blood pressure valsartan amlodipine
safety and efficiency of γδ t cell against hepatocellular liver cancer

Conditions: Liver Cancer

Summary: in this study, effects of γδt cells on human hepatocellular liver cancer in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

liver tumor will be removed using tumor reducing surgery such as cryosurgery. pbmc of the patient will be separated from peripheral blood. after making them potential cancer killer γδ t cell and dc-cik, they will be infused to the patients as an immunotherapy treatment.

Eligibility criteria:
inclusion criteria: 1. age:18-75 2. karnofsky performance status \>50 3. diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive cryosurgery, gd tcells/ dc-cik. 6. life expectancy: greater than 3 months 7. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other kinds of cancer 2. history of coagulation disorders or anemia 3. patients with heart disease and diabetes

Keywords: immunotherapy, γδ t cell, heptocellular liver cancer
a neo-adjuvant chemotherapy immunotherapy in resectable escc study

Conditions: The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma

Summary: research purpose 1: to evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (escc) in the real-world setting. research purpose 2: to analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (escc) in the real-world setting. research purpose 3: to understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced escc in the

research purpose 1: to evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (escc) in the real-world setting. research purpose 2: to analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (escc) in the real-world setting. research purpose 3: to understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced escc in the

Eligibility criteria:
inclusion criteria: age ≥ 18 years (including 18 years old); ecog 0 or 1; patients with esophageal squamous cell carcinoma judged to be resectable (including initially non-resectable) by the researcher received esophageal radical surgery and neoadjuvant immune chemotherapy before surgery clinical staging belongs to: t1b-4nanym0; exclusion criteria: patients without complete medical information; received other anti-tumor treatment before surgery; received radiotherapy treatment; judged by the researcher, have other conditions unsuitable for participating in this clinical study. hide hide contacts/locations
protected tavr: stroke protection with sentinel during transcatheter aortic valve replacement

Conditions: Stroke

Summary: to demonstrate that use of the sentinel® cerebral protection system significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (tavr).


Eligibility criteria:
inclusion criteria: * subject has documented aortic valve stenosis and is treated with an approved tavr device via transfemoral access * subject has the recommended artery diameter at the site of filter placement per the sentinel® cerebral protection system instructions for use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery. * subject (or legal representative) provides written informed consent. exclusion criteria: * subject has arterial stenosis \>70% in either the left common carotid artery or the brachiocephalic artery. * subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium. * subject has compromised blood flow to the right upper extremity. * subject has access vessels with excessive tortuosity. * subject has uncorrected bleeding disorders. * subject is contraindicated for anticoagulant and antiplatelet therapy.
evaluation of different disease control indices in children with asthma and rhinitis

Conditions: Asthma; Rhinitis

Summary: in this study will be consecutive enrolled children with asthma (classified according to gina guidelines) and rhinitis (classified by aria guidelines); the investigators will research clinical personal and parental history regarding allergic diseases, exposition to passive smoking and interpretate hematochemical parameters markers of atopy. skin prick tests will be performed. in this study the investigators will evaluate lung function parameters (spirometry with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry, respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide at different flows, exhaled and nasal temperature, nasal cytology. the aim of the study will be to evaluate possible correlation between these different parameters and clinical status of the patients.

each patients will be evaluated by spirometry and then he will undergo exercise challenge in order to evaluate exercise-induced bronchoconstriction as a marker of asthma control. the test of the challenge will be correlate with childhood asthma control test score,levels of control (gina classification)and the different markers of airway inflammation and atopy.

Eligibility criteria:
inclusion criteria: * patient with asthma and rhinitis exclusion criteria: * age \<5 years * chronic respiratory diseases

Keywords: asthma rhinitis eib exhaled nitric oxide lung function vitamin d
a difference in subclavian vein catheterization between supine and lateral tilt position - stage i

Conditions: Catheterization; Posture

Summary: central venous catheterization is widely used for various purposes during surgery. for central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. the cross - sectional area of the subclavian vein is an important factor to increase success rate. several studies have reported that the trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. however, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. the ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity. in the first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.


Eligibility criteria:
inclusion criteria: - the patients who receive elective neurosurgical surgery and require central venous catheter exclusion criteria: * the patients who have puncture site infection * the patients who have chemoport, pacemaker in right subclavian vein * the patients who had received right mastectomy or right pneumonectomy * other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)
comparison of two biphasic insulin aspart 30 treatment regimens in subjects with type 2 diabetes not achieving hba1c treatment targets on oads alone

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of hba1c below 7% is not reached by oad (oral anti-diabetic drugs) alone.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for a minimum of 6 months prior to visit 1 * hba1c at least 7.0 % - maximum 11 % at screening * subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed) * an antidiabetic regimen that has been stable for at least 3 months prior to screening * an antidiabetic regimen that includes a minimum of 2 oads * oads dosed at least 50% of the maximum recommended dose exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) * the receipt of any investigational medicinal product within one month prior to this trial * suffer from a life threatening disease (cancer) * cardiac disease: class iii or iv congestive heart failure (chf), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening * hepatic insufficiency (alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 2 times the central laboratory's upper reference limit) * renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females * recurrent hypoglycaemia or hypoglycaemic unawareness * anemia (haemoglobin below 10 mg/dl)
written exposure therapy for post-traumatic stress syndrome

Conditions: Post Traumatic Stress Disorder

Summary: to investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder

a non-inferiority trial in jama psychiatry showed that written exposure therapy (wet) was non-inferior to a gold standard cbt treatment. in comparison to other trauma-focused cbt protocols, wet generally demands less therapist-time, and specifically, less than half compared to cbt that consists of 12 weekly sessions á 60 minutes. the aim of this study is to translate and replicate these results in a swedish context. this first step is a small feasibility trial which will guide a subsequent large-scale trial.

Eligibility criteria:
inclusion criteria: * meet criteria for ptsd. * if taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry. * ≥ 18 years * situated in sweden * be able to express themselves in swedish, both in verbally and written form. * informed consent exclusion criteria: * other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the mini) * ongoing cbt for trauma * ongoing trauma-related threat (e.g. living with a violent spouse)

Keywords: ptsd written exposure therapy
safety of intravenous lidocaine infusions

Conditions: Neuropathic Pain

Summary: the purpose of this study is to prospectively determine the side effects profile in adults with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body weight, infused over 45 minutes.

eligibility criteria: adults \> 18 yrs with chronic central or peripheral neuropathic pain at the st joseph's health care pain clinic between june and december 2009. outcome measures: all side effects spontaneously reported. sedation, nausea, dizziness by visual analog score q 15 minutes; hemodynamic data q 5 minutes during and after infusion for 30 minutes. daily diary of side effects and visual analogue score of pain for 7 days post-infusion.

Eligibility criteria:
inclusion criteria: * adult outpatients \> 18 years \< 80 years diagnosed with chronic neuropathic pain exclusion criteria: * unable to provide informed consent * unable to speak and understand english * liver, kidney, or cardiac failure * allergy to lidocaine

Keywords: lidocaine,intravenous infusions,neuropathic pain,side effects
roles of t helper 1 cytokines in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the mechanism of β cell destruction in type 1 diabetes is not exactly known, our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction.

t helper (h)1 cells are known to have important roles in the destruction or/and dedifferentiation of β-cells in type 1 diabetes (t1d). significant increase in ifn-γ-producing th1 cells in the pancreas and in the serum levels were determined in type 1 diabetic patients at diabetes oneset. this data indicated that this proinflammatory mediator serve as a biomarker of advanced autoimmunity. we aimed to investigate the relationship between th1 cytokines (ifn-γ, il-2 and tnf-α) and t1d and the effect of those cytokines on β-cell function.

Eligibility criteria:
inclusion criteria: * patients giving consent to participate the study * patients with type 1 diabetes according to who definiton exclusion criteria: * acute and chronic inflammatory diseases, * significant concomitant diseases which may interfere with glucose metabolism * cancers, * hemoglobinopathies, * recently received antibiotics, * drugs influencing β-cell function and * insulin sensitivity or anti-inflammatory drugs * recent history of trauma

Keywords: type 1diabetes ifn γ il-2 tnf α